MAUDE Adverse Event Report: TOSOH CORPORATION TOSOH HLC-723G8 ANALYZER G8

Model Number G8

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Readings (2460)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/28/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluation by manufacturer: a field service engineer (fse) was dispatched to the customer's facility to address the reported issue.Fse confirmed reported problem of biorad control level 3 running low on customer established qc range.Fse replaced the sample loop for the injection valve, performed calibration run and still running low.Customer replaced the column, performed calibration again and qc l3 still running low.Fse replaced the hemolysis & wash solution, performed calibration and ran biorad controls lot# 38541 & 38543 and they completed successfully within customer's established ranges.Fse also ran tosoh controls lot# 7065 and they also completed successfully within acceptable range.Fse successfully completed a 10 times precision on a random normal patient.No further action required by field service.The g8 instrument is functioning as expected.A 13-month complaint history review and service history review for similar complaints for the g8, serial number (b)(4), was performed through aware date.There were two (2) similar complaints identified during the search period, which includes this event.The g8 operator's manual under chapter 1 - introduction and applications, section 1.6 provides detailed instruction on hemolysis & wash solution installation.Quality control: in order to monitor and evaluate the accuracy and precision of the analytical performance, controls should be assayed daily and after column replacement.Tosoh suggests running at least two levels of quality control material.The mean of one should be in the non-diabetic range (4-7% hba1c) with the second in the range of 9-12% hba1c.If the value of one or more control specimens is out of the acceptable range, recalibrate the system and rerun the controls before testing patient samples.Qc materials should be used in accordance with local, state, federal and accredited organizations.Controls should be diluted with hsi hemolysis & wash solution to obtain an optimal total area (ta) in the range of 700-3000.However a ta in the range of 500-4000 is acceptable and reportable for whole blood specimens.The most probable cause of the reported event was due to empty hemolysis & wash solution.

Event Description

A customer reported level 3 (l3) bio-rad lot 38540 was running low on customer established quality controls (qc) run on the g8 instrument.Bio-rad lot 38540 target range for l3: 12.42 - 15.17; customer's established range result: 13.3 - 13.9, 13.1 & 13.3.The customer reran with mac controls and l3 was in range.Technical support specialist recommended that customer reestablish their l3 ranges and rerun a sample.The following run completed within acceptable range, but customer insisted on an onsite service.A field service engineer (fse) was dispatched to address the reported event, which resulted in delay in reporting of patient results for hemoglobin a1c (hba1c).There was no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

• Brand Name: TOSOH HLC-723G8 ANALYZER G8
• Type of Device: G8
• Manufacturer (Section D): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo, japan 10586 23; JA 1058623
• Manufacturer (Section G): TOSOH CORPORATION (MANUFACTURER); shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo, japan 10586 23; JA 1058623
• Manufacturer Contact: doria esquivel ; 6000 shoreline court; suite 101; south san francisco, CA 94080 ; 6509368123
• MDR Report Key: 8280117
• MDR Text Key: 136147959
• Report Number: 8031673-2018-05440
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131580
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G8
• Device Catalogue Number: 021560
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/25/2019
• Distributor Facility Aware Date: 12/28/2018
• Device Age: 7 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 01/25/2019
• Initial Date Manufacturer Received: 12/28/2018
• Initial Date FDA Received: 01/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1